Collection device and material

ABSTRACT

Swabs, materials and methods of making the same include randomly arranged sea-island bicomponent fibers which have randomly splayed terminal ends. According to certain embodiments, swabs are provide which include an applicator, and sea-island bicomponent fibers attached to the applicator, wherein at least about 70% of the fibers comprise randomly splayed terminal ends of the islands of said bicomponent fibers along a length of about 45% or less from said ends, and wherein the bicomponent fibers comprise 10-3000 island parts per fiber.

The present application is a continuation of application Ser. No.15/007,629 (issued as U.S. Pat. No. 10,094,745) filed Jan. 27, 2016,which is a continuation of application Ser. No. 13/625,195 (issued asU.S. Pat. No. 9,279,747), filed Sep. 24, 2012, which is a continuationof application Ser. No. 12/849,343 (issued s U.S. Pat. No. 8,334,134)filed Aug. 3, 2010, which claims benefit of U.S. Provisional ApplicationNo. 61/326,466 filed Apr. 21, 2010, the entire contents of each of whichis incorporated herein by reference.

TECHNICAL FIELD

The present disclosure describes a swab, and collection material for usetherein, for collecting biological specimens.

BACKGROUND

Devices, such as swabs, for collecting biological specimens of organicmaterial are known in the field of clinical and diagnostic analyses,which generally include a cylindrical rod or stick containing on acollection end or tip a wad of fiber material, such as rayon or anatural fiber such as cotton, with hydrophilic properties to allow rapidabsorption of the quantity of specimen to be collected and tested.Stable adherence of the fiber wrapped around the end or tip of the rodor stick is generally achieved by gluing.

Collection swabs containing the collected material are often immersed ina culture media, such as in a test tube, vial, culture dish, or culturebottle, soon or immediately after collection to preserve and conservethe collected specimen during storage and/or transport to, for example,an analytical laboratory. Collection swabs and devices of the prior artare described, for example, in EP0643131 and

WO2004/086979.

SUMMARY

Devices, such as swabs, and materials of the present disclosure, andmethods of making same, include randomly arranged sea-island bicomponentfibers which have randomly splayed terminal ends.

The present disclosure provides a swab for collecting and releasing abiological sample containing an applicator and sea-island bicomponentfibers, wherein at least about 85% of the fibers comprise randomlysplayed terminal ends of the islands of said bicomponent fibers along alength of about 50% or less from the ends.

The swab of present disclosure contain fibers attached to an end portionof the applicator, such as by adhesive.

The present disclosure provides a method of forming the swab of thedisclosure which includes adhering the bicomponent fibers to theapplicator, removing a portion of the sea component of the bicomponentfibers in a heated alkaline solvent, and forming the randomly splayedfibers by application of mechanical force to the ends of the fiberswhich have had the sea component removed.

The present disclosure provides a method of collecting a biologicalsample which includes contacting the swab of the disclosure with asource of biological material such that a sample of the material isretained by the swab.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 provides an end view of a bicomponent fiber of PET/PET.

FIG. 2 is an electron micrograph of randomly arranged sea-islandbicomponent PET/PET fibers which have randomly splayed terminal ends.

FIG. 3 is a photograph of an experimental swab with an unsplit swabstick head.

FIG. 4 is a photograph of an experimental swab with a full split swabstick head.

DETAILED DESCRIPTION

Devices, such as swabs, and materials of the present disclosure, andmethods of making same, include randomly arranged sea-island bicomponentfibers which have randomly splayed terminal ends.

Materials of the present disclosure may be included as a high absorbencymember of medical swab devices. The “splittable” flock fiber materialsof the present disclosure attached to the end of a thin “stick-like”polymeric shaft are described and contemplated herein as swabs of thepresent disclosure. The flock fibers of the disclosure, which arephysico-chemically “split” at the end of the material, provide a fibrousmaterial with fibrous surface area which increase the overall surfacearea of the fibrous mass. This leads to a higher degree of fluidabsorption by the fibrous mass.

The materials of the disclosure may include micro- and nano-fibers, suchas bicomponent sea-island materials. Segmented pie materials may also beused. Bicomponent sea-island materials and segmented pie materials areknown and described, for example in Ndaro et al Journal of EngineeredFibers and Fabrics, volume 2, Issue 4, 2007 “Splitting ofIslands-in-the-Sea Fibers (PA6/COPET) During Hydroentanging ofNonwovens”; and Fedorova, Nataliya “Investigation of the Utility ofIslands-in-the-sea Bicomponent Fiber Technology in the SpunBond Process”Ph.D. Dissertation, North Carolina State University, Raleigh, N.C.(2006); as well as in U.S. Patent Application Publication Nos.:20100075143 (FIBER STRUCTURE AND METHOD FOR PRODUCTION THEREOF),20100068516 (THERMOPLASTIC FIBER WITH EXCELLENT DURABILITY AND FABRICCOMPRISING THE SAME), and 20100029158 (ISLANDS-IN-SEA TYPE COMPOSITEFIBER AND PROCESS FOR PRODUCING SAME), And WO2002042528 (A SEA-ISLANDTYPED COMPOSITE FIBER USED IN WARP KNITTING, AND A PROCESS OF PREPARINGFOR THE SAME), WO2002042529 A SEA-ISLAND TYPE COMPOSITE FIBER FOR RAISEDWARP KNIT FABRIC, AND A PROCESS OF PREPARING FOR THE SAME), WO2002088438(A SEA-ISLAND TYPED CONJUGATE MULTI FILAMENT COMPRISING DOPE DYEINGCOMPONENT, AND A PROCESS OF PREPARING FOR THE SAME), and as arecommercially available from, for example, Kolon Industry, Kumi City,Kyungbuk, Korea and generally described as ROJEL—polyester/polyesterconjugated fiber yarn (sea/island) or SPECIAL TYPE OFROJEL—polyester/nylon conjugated fiber yarn (sea/island); or HyosungCorporation, Ulsan City, Kyungbuk, Korea and generally described asMIPAN XF—Nylon/polyester conjugated yarn (pie-wedge cross-section).

In the islands-in-sea type composite fiber of the presently describedmaterial, an easily soluble polymer is incorporated for the sea portionand preferably contains at least one polymer easily soluble in aqueousalkali solutions, such as polylactic acid, super high molecular weightpolyalkyleneoxide-condensate polymers, polyethyleneglycolcompound-copolymerized polyesters, and copolymerized polyesters ofpolyethylene glycol (PAG) compounds with 5-sodium sulfoisophthalic acidor dimethyl-5-sulfoisophthalate sodium salt (DMIS). Polyester seamaterials may include alkali soluble copolymer polyester materials withpolyester mainly containing polyethylene terephthalate of more than 90mole percent as island component (such as is described, for example, inWO2002042528, the entire contents of which is incorporated herein byreference).

The islands-in-sea type bicomponent composite fiber of the presentdisclosure contains a sea part containing or composed of polymer ofgreater solubility than a plurality of island parts containing orcomposed of a less soluble polymer, in the cross-sectional profile ofwhich the number of the island parts is about 10, 24, 36, 37, 64 or 240islands per fiber, or ranges of islands per fiber between any of 10, 24,36, 37, 64, 240 or 3000 islands per fiber.

The island component of the bicomponent composite fiber of the presentdisclosure may be a polyamide, such as nylon, or a polyester. Examplesof the polyamide include polymers having an amide bond, such as nylon 6,nylon 66, nylon 610, and nylon 12. The polyester is not particularlylimited as long as it is a polymer synthesized from dicarboxylic acid oran ester-forming derivative and diol or an ester-forming derivativethereof and can be used as the fiber. Specific examples thereof includepolyethylene terephthalate, polytrimethylene terephthalate,polytetramethylene terephthalate, polycyclohexylenedimethyleneterephthalate, polyethylene-2,6-naphthalene dicarboxylate,polyethylene-1,2-bis(2-chlorophenoxy)ethane-4,4′-dicarboxylate and thelike. In an embodiment of the present invention, a polyethyleneterephthalate or a polyester copolymer containing mainly an ethyleneterephthalate unit, may be used.

The islands-in-sea type bicomponent composite fiber of the presentdisclosure have a linear mass density in the range of about 1-7 deniers,alternatively in the range of about 2 to 6 deniers or the range of 2 to5.8 deniers (or 2.22 to 6.49 dtex) wherein a denier is the mass in gramsper 9000 meters of fiber and dtex is the mass in grams per 10,000meters. The diameter (Ø, in centimeters) of a bicomponent compositefiber may be estimated from the following formula, wherein p representsa materials density in grams per cubic centimeter:

$\varnothing = \sqrt{\frac{4 \times {10^{- 6} \cdot {dtex}}}{\pi\rho}}$

Estimating the fiber specific gravity as being equal to 1 (specificgravity values of common fiber polymers according to Gafe et al(“Polymeric Nanofibers and Nanofiber Webs: A New Class of Nonwovens”INTC 2002: International Nonwovens Technical Conference (JointINDA—TAPPI Conference), Atlanta, Ga., Sep. 24-26, 2002) are as follows:0.92 (polypropylene or PP), 1.14 (polyamide 66 or nylon or PA66) and1.38 (polyethylene terephthalate or PET)), the diameter of bicomponentcomposite fiber of the present disclosure having a linear mass densityin the range of 2 to 5.8 deniers would be about 16.7 μm to 28.6 μm.

The islands of the bicomponent composite fibers of the presentdisclosure have a mass linear density of about 0.01 to about 0.3deniers, or about 0.05 to about 0.2 deniers, or about 0.06 to about 0.16deniers, depending on the linear mass density of the bicomponentcomposite fibers of the present disclosure.

The islands-in-sea type bicomponent composite fibers of the material ofthe present disclosure have a length, or cut length, of about 10 toabout 100 thousandths of an inch (about 254 μm to about 2,540 μm), orabout 20 to about 90 thousandths of an inch, or about 20 to about 80thousandths of an inch, or about 20 to about 70 thousandths of an inch,or about 20 to about 60 thousandths of an inch.

At least about 50%, 55%, 60%, 70%, 75%, 80%, 85%, 90% or 95% (by number)of the islands-in-sea type bicomponent composite fibers of the materialof the present disclosure contain randomly splayed, or split and spread,terminal ends along a length of about 50%, 45%, 40%, 35%, 30%, 25%, 20%,15% or 10% or less from one end.

At least about 50%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 50% or less from one end.

At least about 50%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 45% or less from one end.

At least about 50%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 40% or less from one end.

At least about 50%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 35% or less from one end.

At least about 50%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 30% or less from one end.

At least about 50%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 25% or less from one end.

At least about 50%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 20% or less from one end.

At least about 50%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 15% or less from one end.

At least about 50%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 10% or less from one end.

At least about 55%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 50% or less from one end.

At least about 55%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 45% or less from one end.

At least about 55%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 40% or less from one end.

At least about 55%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 35% or less from one end.

At least about 55%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 30% or less from one end.

At least about 55%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 25% or less from one end.

At least about 55%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 20% or less from one end.

At least about 55%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 15% or less from one end.

At least about 55%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 10% or less from one end.

At least about 60%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 50% or less from one end.

At least about 60%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 45% or less from one end.

At least about 60%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 40% or less from one end.

At least about 60%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 35% or less from one end.

At least about 60%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 30% or less from one end.

At least about 60%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 25% or less from one end.

At least about 60%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 20% or less from one end.

At least about 60%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 15% or less from one end.

At least about 60%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 10% or less from one end.

At least about 70%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 50% or less from one end.

At least about 70%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 45% or less from one end.

At least about 70%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 40% or less from one end.

At least about 70%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 35% or less from one end.

At least about 70%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 30% or less from one end.

At least about 70%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 25% or less from one end.

At least about 70%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 20% or less from one end.

At least about 70%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 15% or less from one end.

At least about 70%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 10% or less from one end.

At least about 75%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 50% or less from one end.

At least about 75%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 45% or less from one end.

At least about 75%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 40% or less from one end.

At least about 75%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 35% or less from one end.

At least about 75%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 30% or less from one end.

At least about 75%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 25% or less from one end.

At least about 75%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 20% or less from one end.

At least about 75%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 15% or less from one end.

At least about 75%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 10% or less from one end.

At least about 80%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 50% or less from one end.

At least about 80%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 45% or less from one end.

At least about 80%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 40% or less from one end.

At least about 80%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 35% or less from one end.

At least about 80%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 30% or less from one end.

At least about 80%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 25% or less from one end.

At least about 80%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 20% or less from one end.

At least about 80%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 15% or less from one end.

At least about 80%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 10% or less from one end.

At least about 85%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 50% or less from one end.

At least about 85%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 45% or less from one end.

At least about 85%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 40% or less from one end.

At least about 85%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 35% or less from one end.

At least about 85%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 30% or less from one end.

At least about 85%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 25% or less from one end.

At least about 85%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 20% or less from one end.

At least about 85%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 15% or less from one end.

At least about 85%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 10% or less from one end.

At least about 90%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 50% or less from one end.

At least about 90%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 45% or less from one end.

At least about 90%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 40% or less from one end.

At least about 90%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 35% or less from one end.

At least about 90%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 30% or less from one end.

At least about 90%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 25% or less from one end.

At least about 90%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 20% or less from one end.

At least about 90%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 15% or less from one end.

At least about 90%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 10% or less from one end.

At least about 95%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 50% or less from one end.

At least about 95%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 45% or less from one end.

At least about 95%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 40% or less from one end.

At least about 95%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 35% or less from one end.

At least about 95%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 30% or less from one end.

At least about 95%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 25% or less from one end.

At least about 95%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 20% or less from one end.

At least about 95%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 15% or less from one end.

At least about 95%, (by number) of the islands-in-sea type bicomponentcomposite fibers of the material of the present disclosure containrandomly splayed, or split and spread, terminal ends along a length ofabout 10% or less from one end.

FIG. 2 is a scanning photograph of an example of material of the presentdisclosure wherein randomly splayed ends of the bicomponent compositefibers is illustrated.

The material of the present disclosure alternatively containsislands-in-sea type bicomponent composite fibers wherein at least about85% to about 95% (by number) of the bicomponent composite fibers containrandomly splayed terminal ends along a length of about 40% or less fromone end. The material of the present disclosure alternatively containsislands-in-sea type bicomponent composite fibers wherein at least about85% to about 95% (by number) of the bicomponent composite fibers containrandomly splayed terminal ends along a length of about 30% or less fromone end.

One average, a material of the present disclosure may containislands-in-sea type bicomponent composite fibers wherein about 100% (bynumber) of the bicomponent composite fibers contain randomly splayedterminal ends along a length of about 20% or less from one end.

The exemplary method of the present disclosure has produced adistribution of fibers containing randomly splayed terminal ends along alength of about 0% to about 10% from the end of the fiber in about 50%(by number) of the fibers, fibers containing randomly splayed terminalends along a length of about 10% to about 20% from the end of the fiberin about 40% (by number) of the fibers, and fibers containing randomlysplayed terminal ends along a length of about 20% to about 100% from theend of the fiber in about 10% (by number) of the fibers.

The bicomponent composite fibers of the material of the presentdisclosure are preferably randomly arranged.

The percent by number of fibers of the present disclosure containingrandomly splayed terminal ends may be evaluated by light microscope(Amscope) at 180× power with a 1 mm calibration scale (NIST) inconjunction with a video camera (Amscope 3.0 megapixel) and suitablevideo analysis software, such as for example, Version 3.0.12.498 Amscopevideo software calibrated to 180×.

A swab of the present disclosure, which includes material of the presentdisclosure, may be any shape adapted for collection, and optionalretention, of biological samples from a host directly or alreadycollected biological fluid or sample. Shapes and sizes of such devicesare known in the art. The swab of the present disclosure is constructedof materials known in the art, such as acrylonitrile-butadiene-styrene(ABS). The swab of the present disclosure is such that the material ofthe present disclosure may be attached to the applicator of the swabthrough an adhesive during a flocking technique known in the art.

An applicator of the swab of the present disclosure may be a rod orrod-like thermoplastic substrate wherein one end is coated, partially,substantially or completely, with an adhesive to anchor or hold fibersof the present disclosure to the substrate in an initial arrangementgenerally perpendicular to the substrate and generally parallel toadjacent fibers to thereby create, for example, a bristle or bristly endon the substrate.

In a method of making devices according to the present disclosure,individual, loose or connected substrate, such as applicator shafts,sticks or rods have adhesive applied by at least one adhesive applicatorcontainer, block, head, nozzle, or roller by, for example, spraying,dipping, rolling, printing or a combination thereof, optionally in ametered fashion, under pressure or by gravity, and in a manner which mayor may not include any combination of linear and/or rotational, such asby axial rotation or spinning, of the adhesive applicator relative tothe applicator.

In the flocking technique of the present disclosure, an electric fieldof alternating or direct current is applied to the fibers in a mannerknow in the art to organize and transport charged fibers to oppositecharged adhesive-covered substrate such that the fibers are held inplace by the tackiness or adhesive strength of the adhesive, only inareas where the adhesive has been applied to produce flock fiber tippedapplicators, or swabs of the disclosure. The technique may includemovement of the substrate, linearly and/or rotationally, such as byaxial rotation or spinning, at any time or throughout the process ofapplying fibers to the adhesive. Where further curing of the adhesive,such as by light or heat, is required, the flock fiber tipped applicatorswab may be treated with light and/or heat so as to cure the adhesive.

Swabs of the disclosure may contain approximately 10⁴ to approximately10¹⁰, or approximately 10⁴ to approximately 10⁹, or approximately 10⁴ toapproximately 10⁸, or approximately 10⁴ to approximately 10⁷, orapproximately 10⁴ to approximately 10⁶, or approximately 10⁴ toapproximately 10⁵, flock fibers per substrate.

Once applied and secured to the substrate of the disclosure by flocking,the sea component of the bicomponent fibers adhered to the substrate orapplicator is partially extracted to the extent described herein, suchas by microwave radiation and sonication, to provide islands of thefibers which are subsequently forced in to a random splayed formation,as described herein by application of, for example, mechanical force,such as by blotting. Alternatively, the sea component may be partiallyextracted to the extent described herein to provide randomly arrangeislands of the fibers by, for example, contacting, applying or admixingwith a heated alkali solvent or solution, which are subsequently forcedin to a random splayed formation, as described herein by application of,for example, mechanical force, such as by blotting. A process of thedisclosure thereby forces substantially perpendicular flocked fibers atthe tip or end of the substrate or applicator device to a randomarrangement with randomly splayed or open islands of the originalbicomponent fiber. The resulting randomly splayed arrangement of theisland fibers are alternatively described as being in a flowerarrangement as a flower flock.

The material of the disclosure may be made in a similar manner withoutrequiring securing of the material to the substrate wherein the seacomponent is partially extracted and subsequent application of, forexample, microwave radiation and sonication, or partial extraction withheat and alkali, and subsequent application of mechanical force, toproduce the randomly splayed fiber arrangement described herein.

Application of heat and alkali solutions or solvents are describedherein as a means of extracting the sea component of the bicomponentfiber. The choice of extraction protocol is dependent of the relativesolubility and properties of the sea and island components such thatother extraction protocols are contemplated based on the bicomponentfiber materials described herein and as are generally available.

The adhesive of the present disclosure is not particularly limited andgeneral and photo or heat cured acrylic-based, polyurethane-based,polyamide-based, polyester-based, vinyl-based and/or two-part epoxyadhesives may be used. Silicones, cyanoacrylates, polyurethanes and/orlatex adhesives may be used. Polyurethane adhesive are generally knownand available, such as from K&W Adhesive Products.

The swabs of the present disclosure are adapted or designed forcollection of, for example, biological samples from oral, nasal, ocular,rectal, urethral, or vaginal orifices of a mammal, such as a human, orpatient.

The swabs may be used and is designed for collection of a biologicalspecimen by contact with the fibers of the device such that the devicemay collect, for example, about 35 to about 200 μl, such as 40, 50, 60,70, 80, 90, 100, 120, 130, 140, 150, 160, 170, 180 or 190 μl, withoutcausing damage or substantial discomfort to the patient during specimencollection.

The swabs of the present disclosure is useful for and in a method ofcollecting biological specimens. A swab of the present disclosure is ofthe type containing a rod terminating with a tip covered in the fibersdescribed herein to allow absorption of said specimens, wherein thefibers cover or substantially cover the tip in the form of a layerapplied by means of flocking.

The present disclosure further provides a method of collecting abiological sample which includes contacting a swab as described hereinwith a source of biological material such that a sample of the materialis retained by the swab.

The swabs of the disclosure may be provided, for example, as a componentpart of a collection, transport, culture and/or transport kit or devicewherein additional specimen handling containers and/or devices areincluded and the swab of the present disclosure is specially adapted tobe integrated with such other container and/or devices to assure, forexample, specimen retention, integrity and/or sterility.

The present disclosure provides a swab for collecting and releasing abiological sample containing sea-island bicomponent fibers, wherein atleast about 85% of the fibers contain randomly splayed terminal ends ofthe islands of said bicomponent fibers along a length of about 50% orless from said ends. The swabs may further contain bicomponent fiberswhich are composed of a first polyester sea material and a secondpolyester island material; the first polyester may have a lower meltingpoint than the second polyester and/or the first polyester may have agreater solubility in alkaline solution than the second polyester. Thealkaline solution may more specifically be a sodium hydroxidesolution—the sodium hydroxide solution may contain about 5% to about 50%by weight sodium hydroxide in water, or alternatively about 10% byweight sodium hydroxide in water. The alkaline solution wherein thefirst polyester sea material is more soluble than the second polyestersea material may be a heated alkaline solution—the heated alkalinesolution alternatively having a temperature of about 170° F. to about190° F., such as about 180° F.

The present disclosure provides a swab, wherein material describedherein is attached to an end portion of an applicator stick or rod. Thematerial may be adhered to the end of the applicator with an adhesive,and the adhesive may be a photocurable acrylic adhesive or apolyurethane adhesive.

The bicomponent fibers of the present disclosure may be composed of apolyethylene terephthalate sea material and a polyamide island material.

The bicomponent fibers of the present disclosure may be composed of orcontain 10-3000 island parts per fiber, 10-240 island parts per fiber,10-64 island parts per fiber, 10-37 island parts per fiber, 10-36 islandparts per fiber, 10-24 island parts per fiber, and/or 24-36 island partsper fiber.

The present disclosure provides the fibrous material of the swabdescribed herein. The fibrous material may be incorporated separately asa part of a device other than a swab, such as a filter or cleaning pador brush.

The present disclosure provides a method of forming a swab of thedisclosure involving adhering the bicomponent fibers to an applicator,removing a portion of the sea component of the bicomponent fibers in analkaline solvent or solution, and forming the randomly splayed fibers bymechanically separating the fibers, such as by blotting, which have hadthe sea component removed.

A similar method is provided herein for formation of the material of thedisclosure involving removing a portion of the sea component of thebicomponent fibers by microwaving and sonicating, or ultrasonicdisruption of, said fibers.

The present disclosure provide a method of forming a swab of thedisclosure involving adhering the bicomponent fibers to an applicatorrod or stick, removing a portion of the sea component of the bicomponentfibers in a heated alkaline solvent or solution, and forming therandomly splayed fibers by mechanical action of mashing or blotting orforce applied to the ends of the fibers which have had the sea componentremoved.

A similar method is provided herein for formation of the material of thedisclosure involving removing a portion of the sea component of thebicomponent fibers in a heated alkaline solvent or solution, and formingthe randomly splayed fibers by mechanical action of mashing or blottingor force applied to the ends of the fibers which have had the seacomponent removed.

The following examples further illustrate the materials and methods ofthe disclosure without limiting same.

Example 1—Swabs

A quantity of (about 30 or so) experimental medical swabs were preparedfrom ABS plastic “sticks” of Puritan Medical Products (Guilford, Me.)with 0.5 mm long (0.020″, nominal length, as determined by aFlock-In-Spect flock fiber length optical measurement instrument)Nylon/PET sea/island type flock fiber. Two adhesive systems wereemployed in these experimental fabrications; the polyurethane rubber(K&W polyurethane adhesive—MECFLOCK L876/1, MEDCODUR H5530 two partpolyurethane adhesive, mixed 85 grams L876/1 resin and 15 grams H5530hardener—product of Kissel and Wolf; cured 3 hours at 110° C. or elsecured 16 hours at 80° C.) and a UV photo-curable adhesive from PuritanMedical Products.

The following materials and instruments were used in fabrication: ABS(plastic) swab sticks (supplied by Puritan); Maag Flockmaschinen Motion(flock activity) Tester SPG 1000; K & W adhesive in a shallow aluminumdish (adhesive depth about 1 cm); photo-curable adhesive inlight-blocked packet; flock screen sifter; and a supply of Nylon/PET 0.5mm long Flock fibers

The experimental swabs were fabricated as follows. The flock activitytester's 4″ diameter aluminum base plate is covered (by sifting) withabout 2 grams of loose flock. This sample of loose flock was mounted onto the bottom electrode pedestal of the Flock Activity Tester. The endof the swab sticks were perpendicularly dipped into the fluid K & Wadhesive to a depth of about 1 cm and slowly removed to produceend-coated swab-sticks. Some swab samples were made using photo-curableadhesive. Water-based acrylic (F1059B Lubrizol Corp.) flock adhesive andother water based adhesives could be used but in some applications maynot be as advantageous in splitting methods under investigation. A 3.5KV/cm strength was applied to the DC electrodes of the Flock ActivityTester (upflocking machine). This causes the flock fibers to alignthemselves and actively move to the top electrode. As this flock isbeing propelled from the bottom to the top electrode, the adhesivecoated tip plastic swab-stick is then placed in the “flock fiber cloud”about 1 cm from the bottom electrode (source of the activated flockfibers). While in the “flock fiber cloud”, the swab-stick was slowlyrotated by rolling the stick held in gripping fingers.

Flock fibers fully adhered to the saturate at the (adhesive wet) end ofthe swab-stick after about a 2 to 5 second flock field immersion time.The swab adhesive was subsequently cured.

Splitting studies were performed on the swab stick samples in thefollowing manner. In this procedure, the flocked end of the swab-stickwas placed into a 400 ml glass beaker containing 50 mls of 5% NaOHsolution (enough NaOH solution to cover the flocked end of theswab-stick). The beaker and swab assembly was then placed in theMicrowave Oven for 1 minute at high power. The beaker and swab was thenSonicated for 1 minute (5 seconds on −5 seconds off) at 60 power. Theflocked swab-sticks were then thoroughly rinsed in tap water.Photographs of the swabs unsplit and split swab-stick heads are show inFIGS. 3 and 4. As an alternative to the use of a microwave andsonication, heated alkaline solution may be used. Mechanical force isused at the ends of the fibers to produce the randomly splayed ends.

The average amount of adhesive and the average amount of flock appliedto the ABS base (sticks) were determined by weight with the followingresults: average weight of “Bare” ABS sticks: 0.5644+/−0.00426 grams;average weight of K & W Adhesive on “Sticks” before flocking: 0.0046grams; and average weight of PET/Nylon Flock on “Sticks”: 0.0135 grams.With an average of 0.0135 grams of sea/island flock fiber on each“stick” this translates to approximately 1.2×10⁵ flock fibers per“stick”.

The water “pick-up” capabilities of the flocked medical swabs wasdetermined by a procedure whereby a number of swab and “stick” materialswere first weighed (dry). Then this same series of flocked swabs and“sticks” were immersed in room temperature (23° C.) water (tips only)for 5 seconds and then reweighed.

The percent water pick-ups of the various swab configurations were thencompared and are presented in Table 1. The results in Table 1demonstrate that the “bare” ABS swab sticks pick-up or capture little orno water. The polyurethane adhesive coated (tip only) swabs picked up orcaptures a little water indicating that the adhesive is a more wettablesurface that the “bare” ABS. The flocked fiber swab picked up orcaptured a measurable amount of water (8.95%) while the flocked andsplit fiber experimental swab picked up or captured the most water(9.25%). The flocked and split fiber swab sample will be expected topick up or capture more water as compared with the un-split flocked swabif longer (1.0 mm) flock were used.

TABLE 1 Average Average Average Number of Weight- Weight After WaterWater Pick-Up Specimen Replicates DRY- Tip Water Dip Pick-Up (based on“dry” Description* Tested (grams) (grams) (grams) stick) “Bare” Swab 120.5661 +/− 0.0052 0.5665 +/− 0.0049 0.0004 0.07% Sticks (negligible)Swab “Sticks” 13 0.5790 +/− 0.0050 0.5802 +/− 0.0049 0.0012 0.21% EndCoated with Adhesive Experimental 13 0.5888 +/− 0.0062 0.6415 +/− 0.00840.0527 8.95% Swab (Not Split) Experimental 12 0.5913 +/− 0.0047 0.6460+/− 0.0077 0.0547 9.25% Swabs (Split)

Several fiber material types (of sea/island fiber) have been evaluated.The nylon/PET (Kolon) and PET/PET (Kolon-Rojel) fibers appear useful inthe fiber flocked medical swab application of the present disclosure.While 0.5 mm long nylon/PET flock fiber were initially investigated,fibers of various sizes may be used and are contemplated.

A sea/island fiber splitting procedure has been developed involving themicrowave oven processing of the flock fiber in a 5% NaOH solutionfollowed by a sonication (ultrasonic disruption) treatment.

Two flock adhesives have been found to hold up to the chemical fibersplitting procedure. These were the two-package polyurethane (clearrubbery) and the photo-curable (clear film plastic) systems. Otheradhesives are contemplated.

All literature and publications referred to and described herein areincorporated herein in their entirety.

We claim:
 1. A swab constructed to collect and release a biologicalsample comprising a liquid, wherein the swab comprises: an applicator;and sea-island bicomponent fibers attached to the applicator, wherein atleast about 70% of the fibers comprise randomly splayed terminal ends ofthe islands of said bicomponent fibers along a length of about 45% orless from said ends.
 2. The swab of claim 1 wherein at least about 70%of the fibers comprise randomly splayed terminal ends of the islands ofsaid bicomponent fibers along a length of about 10% or less from saidends.
 3. The swab of claim 1 wherein at least about 70% of the fiberscomprise randomly splayed terminal ends of the islands of saidbicomponent fibers along a length of about 15% or less from said ends.4. The swab of claim 1 wherein at least about 70% of the fibers compriserandomly splayed terminal ends of the islands of said bicomponent fibersalong a length of about 20% or less from said ends.
 5. The swab of claim1 wherein at least about 70% of the fibers comprise randomly splayedterminal ends of the islands of said bicomponent fibers along a lengthof about 25% or less from said ends.
 6. The swab of claim 1 wherein atleast about 70% of the fibers comprise randomly splayed terminal ends ofthe islands of said bicomponent fibers along a length of about 30% orless from said ends.
 7. The swab of claim 1 wherein at least about 70%of the fibers comprise randomly splayed terminal ends of the islands ofsaid bicomponent fibers along a length of about 35% or less from saidends.
 8. The swab of claim 1 wherein at least about 70% of the fiberscomprise randomly splayed terminal ends of the islands of saidbicomponent fibers along a length of about 40% or less from said ends.9. The swab of claim 1 wherein at least about 80% of the fibers compriserandomly splayed terminal ends of the islands of said bicomponent fibersalong a length of about 10% or less from said ends.
 10. The swab ofclaim 1 wherein at least about 80% of the fibers comprise randomlysplayed terminal ends of the islands of said bicomponent fibers along alength of about 15% or less from said ends.
 11. The swab of claim 1wherein at least about 80% of the fibers comprise randomly splayedterminal ends of the islands of said bicomponent fibers along a lengthof about 20% or less from said ends.
 12. The swab of claim 1 wherein atleast about 80% of the fibers comprise randomly splayed terminal ends ofthe islands of said bicomponent fibers along a length of about 25% orless from said ends.
 13. The swab of claim 1 wherein the at least about80% of the fibers comprise randomly splayed terminal ends of the islandsof said bicomponent fibers along a length of about 30% or less from saidends.
 14. The swab of claim 1 wherein the at least about 80% of thefibers comprise randomly splayed terminal ends of the islands of saidbicomponent fibers along a length of about 35% or less from said ends.15. The swab of claim 1 wherein the at least about 80% of the fiberscomprise randomly splayed terminal ends of the islands of saidbicomponent fibers along a length of about 40% or less from said ends.16. The swab of claim 1 wherein said bicomponent fibers comprise a firstpolyester sea material and a second polyester island material.
 17. Theswab of claim 1 wherein the fibers are attached to an end portion ofsaid applicator by an adhesive.
 18. The swab of claim 1 wherein saidbicomponent fibers comprise a polyethylene terephthalate sea materialand a polyamide island material.
 19. A method of forming the swab ofclaim 17 comprising adhering the bicomponent fibers to said applicator,removing a portion of the sea component of said bicomponent fibers in aheated alkaline solvent, and forming said randomly splayed fibers byapplication of mechanical force to the ends of said fibers which havehad said sea component removed.
 20. A method of collecting a biologicalsample comprising contacting the swab of claim 1 with a source ofbiological material such that a sample of the material is retained bythe swab.